Kornimate/medical-research-clean huggingface dataset:
optimising screening for early disease detection in familial pulmonary fibrosis

Conditions: Pulmonary Fibrosis Idiopathic Familial

Summary: in this study the prognostic value of the current screening parameters for familial pulmonary fibrosis (fpf) will be investigated by looking at the screenings of 200 first-degree relatives of patients with fpf. also insight in the natural history of early fpf, and the necessary interval between screenings visits will be investigated.

familial pulmonary fibrosis (fpf) is a fatal lung disease that is often not diagnosed until a significant portion of the lung function is lost. median survival after diagnosis is 3 to 5 years. as treatment can only slow down lung function decline, early disease detection is essential to provide timely therapeutic support. as first-degree relatives of patients with fpf are at high risk of developing pulmonary fibrosis as well, a screening protocol has been put in place. however, the value of current screening parameters to detect early asymptomatic disease as well as the optimal interval between screening appointments are unknown. a prospective study into the prognostic value of these screening markers in the target population and the appropriate clinical setting is needed to develop an evidence-based screening protocol. there will be an emphasis on easily operable parameters that may allow for redirection of (part of the) screening activities to the general practice in the future.

Eligibility criteria:
inclusion criteria: * asymptomatic first-degree relative of patients with familial pulmonary fibrosis (fpf) exclusion criteria: * a previous diagnosis of interstitial lung disease (ild) * minors (aged \<18 years) * pregnant note: woman who are pregnant at the start of the study or at the time of the hrct are not allowed to participate. if a participant gets pregnant at a later stage during the study, she will not be excluded from the study. to be able to account for a potential effect of pregnancy during data analysis, female participants can be asked if they are pregnant at every visit.

Keywords: pulmonary fibrosis familial screening asymptomatic family members first-degree
patients with refractory, metastatic cancer harboring kit mutation or amplification to investigate the clinical efficacy and safety of imatinib therapy

Conditions: Advanced, Refractory Cancer

Summary: kit is a receptor tyrosine kinase that binds to stem-cell factor (scf), activating a series of downstream effector pathways. kit is an established therapeutic target in cancer with activating mutations of kit, such as gastrointestinal stromal tumors (gist), and significant benefit is achieved with various small molecule inhibitors of kit such as imatinib mesylate. moreover, there is increasing evidence implicating kit mutations as tractable therapeutic targets in melanoma. additional information is required to characterize the functional role of low-frequency mutations in kit and to determine whether amplification of wild type kit is a real driver that can be targeted therapeutically. except gist and melanoma, other solid cancers were reported to have kit mutation even in low frequency. a molecular profiling of the tumors of patients referred to the phase i clinic at the m.d. anderson cancer center showed kit mutation in 7 patients in total of 431 patients (2%). hence, the investigators planned this study to apply the molecularly targeted agent, imatinib to various types of cancers harboring kit mutation or amplification.


Eligibility criteria:
inclusion criteria: 1. age ≥ 20 2. advanced, refractory cancer patients who failed standard of care (soc) 3. kit aberration: defined as mutation in exons 9, 11, 13, 17 or 18, or nanostring cnv by quantitative pcr (greater than 3 copies) or subject with specific sensitivity (z-score\<-1) to imatinib by avatar scan whose disease has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy 4. ecog performance status of 0\~2 5. measurable or evaluable lesion per recist 1.1 criteria 6. adequate marrow, hepatic, renal and cardiac functions * serum aspartate transaminase (ast) and serum alanine transaminase (alt) ≤ 2.5 x upper limit of normal (uln), or ast and alt ≤ 5 x uln if liver function abnormalities are due to underlying malignancy * total serum bilirubin ≤ 1.5 x uln * absolute neutrophil count(anc) ≥ 1,500/ul * platelets ≥ 100,0000/ul * hemoglobin ≥ 9.0 g/dl 7. provision of a signed written informed consent exclusion criteria: 1. severe co-morbid illness and/or active infections 2. pregnant or lactating women 3. history of major surgery or radiotherapy within 4 weeks 4. active cns metastases not controllable with radiotherapy or corticosteroids (however, cns metastases (except for leptomeningeal seeding) are allowed if controlled by gamma knife surgery or surgery or radiotherapy or steroid) 5. known history of hypersensitivity to study drugs
treatment for acute spinal cord injury

Conditions: Spinal Cord Injury

Summary: this clinical trial aims to treat a damaged spinal cord by injecting your own bone marrow stromal cells (autologous bone marrow stromal cells) into cerebrospinal fluid through the lumbar puncture, and assess the safety and efficacy of the procedure.


Eligibility criteria:
inclusion criteria: * spinal cord injury is confirmed with mri * methylprednisolone therapy according to this study can be started within 8 hours after the injury * bone marrow stromal cells (bmscs) incubation can be started within 72 hours after the injury * age between 15 and 60 * with the informed consent of obtaining bone marrow and injecting incubated bmscs. exclusion criteria: * complete disruption of spinal cord * central spinal cord injury * spinal canal stenosis before the injury * brain or spinal cord disease before the injury * positive serologic test in at least one of the following; hbs antigen, hcv antibody, hiv antibody, or htlv-1 antibody * pregnancy

Keywords: spinal cord injury central nervous system regeneration bone marrow stromal cells transplantation
a double-blind study to evaluate the safety and pharmacokinetics of l-ofloxacin (rwj 25213) in subjects with hiv infection

Conditions: HIV Infections

Summary: to determine the safety and pharmacokinetics of l-ofloxacin (rwj 25213) in patients with hiv infection.


Eligibility criteria:
inclusion criteria patients must have the following: hiv infection. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * active opportunistic infection or neoplasm. * high likelihood of death during study. * significant ophthalmologic, renal, hepatic, cardiovascular, hematologic, neurologic, psychiatric,respiratory, or metabolic disease. * donation of \> 1 unit blood or acute loss of blood within one month of study entry. patients with the following prior conditions are excluded: * history of opportunistic infection. * previous allergic reaction to ciprofloxacin, norfloxacin, or any other quinolone. prior medication: excluded: use of any investigational agent within 7 days of entry into study. use of any medication within 3 days prior to entry (7 days for azt). alcohol or drug abuse.

Keywords: anti-infective agents, quinolone ofloxacin acquired immunodeficiency syndrome
microvascular invasion for guiding treatment of barcelona clinic liver cancer stage b hepatocellular carcinoma

Conditions: Radiomics; Hepatocellular Carcinoma (HCC); Transcatheter Arterial Chemoembolization (TACE); Microvascular Invasion (MVI); Multi-kinase Inhibitors (MKI)

Summary: the goal of this observational study is to explore the role of prediction of microvascular invasion by radiomics based on pre-treatment magnetic resonance imaging for guiding treatment of barcelona clinic liver cancer stage b hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: 1. age 18-75 years; 2. bclc stage b hcc; 3. received no previous anti-cancer treatment; 4. at least 1 measurable intrahepatic lesion based on the response evaluation criteria in solid tumors criteria (recist) 1.1; 5. adequate hematological, liver, renal function: 1. absolute neutrophil count ≥ 1.5×109/l; 2. platelet count ≥ 100×109/l; 3. hemoglobin concentration ≥ 90 g/l; 4. albumin ≥ 28 g/l; 5. total bilirubin \< 1.5 times the upper limit of normal; 6. alanine aminotransferase and aspartate aminotransferase \< 5 times the upper limit of normal; 7. blood urea nitrogen and serum creatinine concentration \< 1.5 times the upper limit of the normal range or less and creatinine clearance rate ≥ 45 ml/min; 6. life expectancy of at least 3 months. exclusion criteria: 1. acute or chronic active hepatitis b (hbv) or c (hcv) infection with hbv-dna \> 2000 iu/ml or 104 copies/ml; hepatitis c virus rna \> 103 copies/ml; hbsag and anti-hcv antibody positive at the same time. those who are below the above criteria after nucleoside based antiviral therapy may be enrolled; 2. life-threatening bleeding event within the past 3 months, including the need for blood transfusion, surgical or local treatment, or continuous medication; 3. history of previous arterial or venous thromboembolic events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary artery embolism, deep vein thrombosis, or any other serious thromboembolism; 4. use of aspirin (\>325 mg/day) or other drugs known to inhibit platelet function such as dipyridamole or clopidogrel for 10 consecutive days within 2 weeks prior to enrollment; 5. uncontrolled hypertension, systolic blood pressure \> 140 mmhg or diastolic blood pressure \> 90 mmhg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy; 6. symptomatic congestive heart failure (new york heart association class ii-iv); symptomatic or poorly controlled arrhythmias; history of congenital long qt syndrome or corrected qt (qtc) \> 500 ms at screening; 7. diagnosis of other malignant tumors within 5 years prior to enrollment; 8. pregnant or lactating women or subjects planning to have a baby during the study period; 9. accompanied with other uncontrolled co-morbidities; 10. co-infection with hiv, known syphilis infection requiring treatment.
pregnancy-related hypertension: adherence to a new type of monitoring

Conditions: Gestational Hypertension; Preeclampsia; Chronic Hypertension With Pre-Eclampsia Complicating Childbirth; HELLP Syndrome

Summary: a large segment of our patient population is diagnosed with hypertensive disorders of pregnancy, including gestational hypertension and pre-eclampsia. new guidelines from the american college of obstetricians and gynecologists recommend postpartum monitoring of blood pressures via blood pressure checks on day 3 postpartum and between days 7-10 postpartum. our purpose is to compare the effectiveness of using a bluetooth-enabled home blood pressure monitoring platform to the standard postpartum office-based blood pressure monitoring in performing the recommended postpartum follow-up for patients with hypertensive disorders of pregnancy.

while inpatient during the postpartum period, patients will be identified who were diagnosed with hypertensive disorders of pregnancy antepartum, intrapartum, or postpartum. these patients will be recruited prior to discharge home. this will be a randomized control trial, non-blinded. the study group will receive a mobile app for postpartum education and an integrated wi-fi connected blood pressure cuff for at-home monitoring for 16 days postpartum. the home bp monitoring will occur twice a day and study team will check the bps twice a day and intervene by phone or text if necessary. the control group will be scheduled for blood pressure checks at the clinic between days 7-10. these groups will be compared with regard to adherence to guidelines from the american college of obstetricians and gynecologists for blood pressure monitoring, antihypertensive initiation after discharge, unscheduled visits, readmission, and attendance of postpartum visit.

Eligibility criteria:
inclusion criteria: * patient must have delivered an infant either at greenville memorial hospital or musc and be willing and able to follow-up with her respective institution. * patient must have been diagnosed with a hypertensive disorder of pregnancy in the antepartum, intrapartum, or postpartum period. exclusion criteria: * \<18 years of age * bmi \>50 (due to limitations in blood pressure cuff size through babyscripts) * non english-speaking * not able to receive phone calls and unlimited texts on cell phone * not able to download and use babyscripts phone application
outcome following surgery to repair rotator cuff tears

Conditions: Rotator Cuff Tear

Summary: there are two ways in which surgeons repair rotator cuff tears. an open method involves making an incision (cut) 5-6 inches in length in the skin and repairing the tear with the skin open, while the arthroscopic method involves making small holes in the skin and using a guiding camera and special equipment to repair the tear. this clinical study is being conducted to study the rate of re-tear (one year following surgery) of rotator cuffs that have been repaired using the arthroscopic technique.

while many studies have researched re-tear rate for rotator cuff tears following open repair, to date there have been no studies evaluating re-tear rate following arthroscopic surgery. arthroscopic rotator cuff repair is less invasive and exposes the patient to fewer risks than open surgery. once this pilot study is completed the next step will be to compare the rate of re-tear, as assessed via magnetic resonance imaging (mri) between the two techniques. if the rate of re-tear is lower following arthroscopic surgery this will provide validation for use of the arthroscopic technique. if, however, the rate of re-tear is higher using the arthroscopic technique, then use of this technique is not justified.

Eligibility criteria:
inclusion criteria: * 1. diagnosis of rotator cuff tear which will involve one of the following:1) history of shoulder pain or weakness 2) ability to illicit pain or weakness with one of the following signs: tenderness of the rotator cuff insertion, palpable crepitus of the subacromial bursa or a palpable defect of the cuff insertion, impingement signs and weakness of the rotator cuff musculature 3) radiological evidence of rotator cuff tear from ultrasound, arthrogram or mri. failed non-operative treatment. size of tear of less than 5 cm and involving 2 or fewer tendons exclusion criteria: * clinical:1. tear as defined by significant muscular wasting, inability to actively forward-flex (strength grade 2/5 or worse), positive drop sign or hornblowers 2. significant tenderness of acromioclavicular or sternoclavicular joints on affected side3. presence of comorbid shoulder instability or evidence of slap lesion4. previous surgery on affected shoulderradiological:1. bony abnormality on standardized series of x-rays consisting of a minimum of an antero-posterior view, lateral \&#8220;y\&#8221; view in the scapular plane, and an axillary view.2. presence of massive cuff tear on mri or ultrasound (defined as \&gt; 5 cm or greater than 2 tendons torn).arthroscopic:1. presence of massive cuff tear as defined above on arthroscopic examination of the joint 2. presence of comorbid conditions: bankart lesion, slap lesion3. inability to complete the repair arthroscopically (eg. partial repair by marginal convergence without direct repair to bone)other:patients who have any contraindication to mri (including claustrophobia, intracranial aneurism clip, cardiac pacemaker, middle ear prosthesis, metallic heart valve prosthesis, prior metal fragment in eye (intraocular lens implant) etc.

Keywords: rotator cuff tear arthroscopic repair
pharmacokinetics and safety profile of ckd-333

Conditions: Hypertension; Dyslipidemias

Summary: compare the pharmacokinetic characteristics and safety between ckd-333 tablet and ckd-330, d086 combination

an open-label, randomized, fasted, single-dose, three-way crossover study to compare the pharmacokinetic characteristics and safety between administration of ckd-333 and coadministration of ckd-330 and d086 in healthy male adults

Eligibility criteria:
inclusion criteria: 1. between 19 aged and 45 aged in healthy male adult 2. body weight more than 50kg and within ideal body weight ±20% exclusion criteria: 1. have clinical significant medical history or disease that cardiovascular system, respiratory system, kidney, endocrine system, hematological system, digestive system , mental illness 2. have a gastrointestinal disease history that can effect drug absorption or surgery 3. sbp(systolic blood pressure)≥140mmhg or sbp\<90mmhg, dbp(diastolic blood pressure(≥90mmhg or dbp\<60mmhg

Keywords: hypertension dyslipidemias ckd-333
efficacy and safety of etelcalcetide (amg 416) in the treatment of secondary hyperparathyroidism (shpt) in patients with chronic kidney disease on hemodialysis

Conditions: Hyperparathyroidism, Secondary

Summary: this study is designed to assess the efficacy and safety of etelcalcetide compared with placebo in the treatment of shpt in patients with chronic kidney disease (ckd) receiving hemodialysis.


Eligibility criteria:
inclusion criteria: * subject understands the study procedures and agrees to participate in the study by giving written informed consent. * subject is 18 years of age or older. * subject must be receiving hemodialysis 3 times weekly for at least 3 months * subject agrees to not participate in another study of an investigational agent during the study. * other inclusion criteria may apply exclusion criteria: * currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(s) within 8 weeks prior to screening. * other investigational procedures while participating in this study are excluded. * anticipated or scheduled parathyroidectomy during the study period. * subject has received a parathyroidectomy within 3 months prior to dosing. * anticipated or scheduled kidney transplant during the study period. * subject has known sensitivity to any of the products or components to be administered during dosing. * subject has participated in a prior clinical trial of amg 416 (also referred to as kai-4169). * subject has received cinacalcet within the 4 weeks prior to screening labs (treatment with cinacalcet is prohibited during the study). * subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the investigator. * other exclusion criteria may apply

Keywords: secondary hyperparathyroidism (shpt), chronic kidney disease (ckd), hemodialysis, parathyroid hormone (pth), hypocalcemia, bone and mineral metabolism
dampening the reproductive axis with continuous kisspeptin

Conditions: Reproductive Disorder; PCOS; Polycystic Ovary Syndrome

Summary: the goal of this study is to assess response to kisspeptin as well as the baseline patterns of luteinizing hormone (lh) secretion in individuals with polycystic ovarian syndrome (pcos).

assignment: all study subjects will undergo the same interventions. baseline lh secretion patterns of individuals with pcos will be compared to their lh secretion patterns while receiving a kisspeptin infusion. delivery of interventions: * prior to the inpatient study visit, the subjects will undergo a review of their medical history, physical exam, and screening laboratories. * on the day of the study, the subjects will have an intravenous (iv) line placed and * undergo up to q10 min blood sampling x 36 hours * receive an infusion of kisspeptin x 24 hours * receive up to two kisspeptin iv boluses

Eligibility criteria:
* ages 18-45 years * a history of clinical diagnosis of pcos or equivalent clinical features * bmi \>18.5 and \<35 kg/m2 * normal blood pressure (systolic bp \ 90 mm hg) * laboratory studies: * negative human chorionic gonadotropin (hcg) pregnancy test prior to kisspeptin administration * hemoglobin no less than 0.5 g/dl below the lower limit of the reference range for healthy women * not using hormonal medication or willing to complete an appropriate washout for that particular medication and its method of administration * no current or recent use of a medication that, in the opinion of a study investigator, can modulate the reproductive axis or willing to complete an appropriate washout for that particular medication and its method of administration * no excessive alcohol consumption (\>10 drinks/week) and/or ongoing use of illicit drugs • any current use of marijuana will be evaluated by a study medical professional to determine if it is expected to impact study participation * not pregnant or trying to become pregnant * not breastfeeding * no history of bilateral oophorectomy (both ovaries removed)

Keywords: reproductive disorders kisspeptin pcos
observational study to evaluate disease course and outcomes in patients treated with esbriet (pirfenidone) for idiopathic pulmonary fibrosis (ipf) in canada

Conditions: Idiopathic Pulmonary Fibrosis

Summary: this is a multi-center, non-interventional study to assess and describe course and outcomes in patients diagnosed with idiopathic pulmonary fibrosis (ipf) who are treated with esbriet (pirfenidone) in canada, by measuring and reporting observed predicted forced vital capacity (fvc) change from baseline on an ongoing basis.


Eligibility criteria:
inclusion criteria: * \> or = 18 years of age * diagnosis of idiopathic pulmonary fibrosis (ipf) * prescribed and/or currently taking esbriet (pirfenidone) for the treatment of ipf exclusion criteria: * hypersensitivity to esbriet (pirfenidone) * concomitant use of fluvoxamine * severe hepatic impairment or end-stage liver disease * severe renal impairment or end-stage renal disease requiring dialysis